Risedronate to Prevent Bone Loss After Sleeve Gastrectomy: Study Design and Feasibility Report of a Pilot Randomized Controlled Trial.

Autor: Swafford AA; Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC USA., Ard JD; Weight Management Center Wake Forest Baptist Medical Center Winston-Salem NC USA., Beavers DP; Department of Biostatistics and Data Science Wake Forest School of Medicine Winston-Salem NC USA., Gearren PC; Weight Management Center Wake Forest Baptist Medical Center Winston-Salem NC USA., Fernandez AZ; Weight Management Center Wake Forest Baptist Medical Center Winston-Salem NC USA., Ford SA; Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC USA., Greene KA; Department of Biomedical Engineering Wake Forest School of Medicine Winston-Salem NC USA., Kammire DE; Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC USA., Nesbit BA; Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC USA., Reed KK; Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC USA., Weaver AA; Department of Biomedical Engineering Wake Forest School of Medicine Winston-Salem NC USA., Beavers KM; Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC USA.
Jazyk: angličtina
Zdroj: JBMR plus [JBMR Plus] 2020 Oct 02; Vol. 4 (10), pp. e10407. Date of Electronic Publication: 2020 Oct 02 (Print Publication: 2020).
DOI: 10.1002/jbm4.10407
Abstrakt: Mounting evidence implicates bariatric surgery as a cause of increased skeletal fragility and fracture risk. Bisphosphonate therapy reduces osteoporotic fracture risk and may be effective in minimizing bone loss associated with bariatric surgery. The main objective of this pilot randomized controlled trial (RCT; Clinical Trial No. NCT03411902) was to determine the feasibility of recruiting, treating, and following 24 older patients who had undergone sleeve gastrectomy in a 6 month RCT examining the efficacy of 150-mg once-monthly risedronate (versus placebo) in the prevention of surgical weight-loss-associated bone loss. Feasibility was defined as: (i) >30% recruitment yield, (ii) >80% retention, (iii) >80% pills taken, (iv) <20% adverse events (AEs), and (v) >80% participant satisfaction. Study recruitment occurred over 17 months. Seventy participants were referred, with 24 randomized (34% yield) to risedronate ( n = 11) or placebo ( n = 13). Average age was 56 ± 7 years, 83% were female (63% postmenopausal), and 21% were black. The risedronate group had a higher baseline BMI than the placebo group (48.1 ± 7.2 versus 41.9 ± 3.8 kg/m 2 ). The 10-year fracture risk was low (6.0% major osteoporotic fracture, 0.4% hip fracture); however, three individuals (12.5%, all risedronate group) were osteopenic at baseline. Twenty-one participants returned for 6-month follow-up testing (88% retention) with all ( n = 3) loss to follow-up occurring in the risedronate group. Average number of pills taken among completers was 5.9 ± 0.4 and 6.0 ± 0.0 in the risedronate and placebo groups, respectively ( p = 0.21), with active participants taking >80% of allotted pills. Five AEs (3.7% AE rate) were reported; one definitely related, four not related, and none serious. All participants reported high satisfaction with participation in the study. Use of bisphosphonates as a novel therapeutic to preserve bone density in patients who had undergone a sleeve gastrectomy appears feasible and well-tolerated. Knowledge gained from this pilot RCT will be used to inform the design of an appropriately powered trial.
Clinical Trial Registration: http://clinicaltrials.gov/show/NCT03411902. Weight Loss With Risedronate for Bone Health. © 2020 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.
(© 2020 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.)
Databáze: MEDLINE
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